Systems and Methods For Communicating Data

ABSTRACT

A wearable medical device includes an electrode assembly having a plurality of ECG sensing electrodes configured to monitor a cardiac condition of a patient using the device, a call button to initiate a call with a remote location and a transceiver configured to communicate information to and from the wearable medical device. The device includes a memory and a controller having at least one processor configured to execute instructions stored in the memory. The instructions include receiving, via actuation of the call button, a request to initiate a communication link with the remote location, providing, via a user interface, a confirmatory prompt that the patient indicate confirmation to proceed with the request to initiate the communication link with the remote location, and initiating, via the transceiver, the communication link to the remote location responsive to the indication of the confirmation to proceed with the request to initiate the communication link.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/805,703 entitled “Systems and Methods for Communicating Data”, filedNov. 7, 2017, which is a continuation of U.S. patent application Ser.No. 15/203,364 entitled “Systems and Methods for Communicating Data”,filed Jul. 6, 2016, now U.S. Pat. No. 9,839,356, which claims thebenefit of priority from U.S. Provisional Patent Application No.62/189,583, entitled “Systems and Methods for Communicating Data” andfiled Jul. 7, 2015, which are incorporated herein by reference in theirentirety.

TECHNICAL FIELD

The present disclosure relates to an external medical device and, insome aspects, to an external medical device configured to communicatewith a remote location.

BACKGROUND

There are a wide variety of electronic and mechanical devices formonitoring and treating patients' medical conditions. In some examples,depending on the underlying medical condition being monitored ortreated, medical devices such as cardiac pacemakers or defibrillatorsmay be surgically implanted or connected externally to the patient. Insome cases, physicians may use medical devices alone or in combinationwith drug therapies to treat patient medical conditions.

One of the most deadly cardiac arrhythmias is ventricular fibrillation,which occurs when the normal, regular electrical impulses are replacedby irregular and rapid impulses, causing the heart muscle to stop normalcontractions and to begin to quiver. Normal blood flow ceases, and organdamage or death can result in minutes if normal heart contractions arenot restored. Because the victim has no perceptible warning of theimpending fibrillation, death often occurs before the necessary medicalassistance can arrive. Other cardiac arrhythmias can include excessivelyslow heart rates known as bradycardia.

Implantable or external pacemakers and defibrillators (such as automatedexternal defibrillators or AEDs) have significantly improved the abilityto treat these otherwise life-threatening conditions. Such devicesoperate by applying corrective electrical pulses directly to thepatient's heart. For example, bradycardia can be corrected through theuse of an implanted or external pacemaker device. Ventricularfibrillation can be treated by an implanted or external defibrillator.

Monitoring devices are also available. For example, such devices operateby monitoring the patient's heart for treatable arrhythmias and, whensuch is detected, the device applies corrective electrical pulsesdirectly to the heart. Wearable pacing devices and/or defibrillatorshave been developed for a certain population of patients, e.g., thosethat may have recently experienced a heart attack, that are susceptibleto heart arrhythmias and are at temporary risk of sudden death, or thatare awaiting an implantable device.

Typically, these external monitoring and/or pacing devices and/ordefibrillators include communication circuits capable of communicatingwith a remote location.

SUMMARY

Preferred and non-limiting aspects or embodiments of the presentinvention will now be described in the following numbered clauses:

Clause 1. A wearable medical device includes monitoring circuitryconfigured to monitor a cardiac condition of a patient using thewearable medical device; and communication circuitry configured toinitiate an audio and/or video communication link with a remotelocation. The remote location is selected based on data associated withat least one of the wearable medical device and the patient using thewearable medical device.

Clause 2. The wearable medical device of clause 1, wherein thecommunication circuitry can initiate the audio and/or videocommunication link by placing a call, and the call can routed to theremote location based on the data associated with at least one of thewearable medical device and the patient using the wearable medicaldevice.

Clause 3. The wearable medical device of any of clause 1 and 2, whereinthe data can include data collected over a period of time during whichthe patient is using the wearable medical device.

Clause 4. The wearable medical device of any of clauses 1 to 3, whereinthe data collected over the period of time can be continuously orsubstantially continuously collected during the period of time.

Clause 5. The wearable medical device of any of clauses 1 to 4, whereinthe monitoring circuitry can be configured to monitor the cardiaccondition of the patient during the period of time.

Clause 6. The wearable medical device of any of clauses 1 to 5, whereinthe data can include compliance data of the patient.

Clause 7. The wearable medical device of any of clauses 1 to 6, whereinthe data can include at least one of an indication of a compliance ofthe patient with a requirement for using the wearable medical deviceduring a period of time, patient training data, and device event data.

Clause 8. The wearable medical device of any of clauses 1 to 7, whereinthe data can include patient training data.

Clause 9. The wearable medical device of any of clauses 1 to 8, whereinthe data can include device abuse information.

Clause 10. The wearable medical device of any of clauses 1 to 9, whereinthe communication circuitry can be configured to automatically initiatethe communication link on detecting at least one of a patient event anda device event.

Clause 11. The wearable medical device of any of clauses 1 to 10,wherein the data can be received from a remote data source.

Clause 12. The wearable medical device of any of clauses 1 to 11,wherein the communication circuitry can initiate the audio and/or videocommunication link with the remote location in response to a userinstruction.

Clause 13. The wearable medical device of any of clauses 1 to 12,wherein the communication circuitry can automatically initiate the audioand/or video communication link with the remote location based on thedata associated with at least one of the wearable medical device and thepatient using the wearable medical device.

Clause 14. The wearable medical device of any of clauses 1 to 13,wherein the communication circuitry can automatically initiate a secondcommunication link concurrently or substantially concurrently with theaudio and/or video communication link with the remote location.

Clause 15. The wearable medical device of any of clauses 1 to 14,wherein the communication circuitry can automatically initiate thesecond communication link with a predetermined other remote locationconcurrently or substantially concurrently with the audio and/or videocommunication link with the remote location.

Clause 16. The wearable medical device of any of clauses 1 to 15,wherein the communications link can include a real-time call includingvoice and/or video communication between the communication circuitry andthe remote location.

Clause 17. The wearable medical device of any of clauses 1 to 16,wherein the communication circuitry can be configured to receive arequest for certain data from the remote location, and the communicationcircuitry can be configured to provide the certain data to the remotelocation in response to the request.

Clause 18. The wearable medical device of any of clauses 1 to 17,wherein the communication circuitry can be configured to provide to theremote location direct access to certain data stored in a memory of thewearable medical device.

Clause 19. The wearable medical device of any of clauses 1 to 18,wherein audio and/or video data can be communicated via the audio and/orvideo communication link, and the communication circuitry can beconfigured to transmit supporting data to the remote location.

Clause 20. The wearable medical device of any of clauses 1 to 19,wherein the wearable medical device can further include a garment wornby the patient, and the garment can include an electrode assemblyincluding a plurality of electrodes. The plurality of electrodes can beconfigured to receive a plurality of different ECG signals from thepatient, and the data can include the plurality of different ECGsignals.

Clause 21. The wearable medical device of any of clauses 1 to 20,wherein the data comprises at least one of monitored physiological data,patient symptom data, location/position data, patient profile andpreferences data, treatment data, and device parameter data. Themonitored physiological data includes information relating to amonitored physiological condition of the patient including dataindicating at least one of an activity level of the patient, monitoredECG data, heart sounds, lung sounds, monitored tissue and/or lungfluids, blood pressure, heart rate, glucose levels, blood oxygen levels,thoracic impedance, respiration rate, sleep data, acoustics, stresslevels of the patient, and a change in a monitored physiologicalconditions. The patient symptom data includes data indicating at leastone of shortness of breath, light headedness, racing heart, skippedbeat, fatigue, fainting, and chest discomfort. The location/positiondata includes information relating a patient's location including atleast one of GPS coordinates, address of location, location within abuilding or a home, position of the patient, and altitude from areference level. The patient profile and preference data includes one ormore patient profile and preferences information including at least onedemographics information, a language preference of the patient, a reasonfor selecting the communication link, data indicating a representativewho assigned the patient the wearable medical device, a primary carephysician or other caregiver assigned to the patient, and insurancedata. The treatment data includes information relating to a treatmentevent including data indicating at least one of a treatment for adetected cardiac event of the patient and treatment parameters. Thedevice parameter data includes data indicating at least one of a batterylevel of a battery pack of the device, a unique device identifier,device type, device technical history, and technical data associatedwith a reported technical issue of the device.

Clause 22. The wearable medical device of any of clauses 1 to 21,wherein the remote location can be further selected based on dataassociated with a plurality of possible remote locations.

Clause 23. The wearable medical device of any of clauses 1 to 22,wherein the wearable medical device can further include a processorconfigured to apply a plurality of rules to the data associated with theplurality of possible remote locations and the data associated with atleast one of the wearable medical device and the patient using thewearable medical device to select the remote location from the pluralityof possible remote locations.

Clause 24. The wearable medical device of any of clauses 1 to 23,wherein the data associated with the plurality of possible remotelocations can include at least one of a schedule of availability of theplurality of possible remote locations, a location of the plurality ofpossible remote locations, and a type of personnel assigned to theplurality of possible remote locations.

Clause 25. The wearable medical device of any of clauses 1 to 24,wherein the wearable medical device can include a wearable cardiacmonitoring device.

Clause 26. The wearable medical device of any of clauses 1 to 25,wherein the wearable medical device can include a wearable cardiacmonitoring and treatment device.

Clause 27. The wearable medical device of any of clauses 1 to 26,wherein the wearable medical device can include a wearabledefibrillator.

Clause 28. The wearable medical device of any of clauses 1 to 27,wherein the wearable medical device can include a wearable pacingdevice.

Clause 29. A wearable medical device includes monitoring circuitryconfigured to monitor a cardiac condition of a patient using thewearable medical device; and communication circuitry configured toinitiate an audio and/or video communication link with at least one of afirst remote location for providing technical support for the wearablemedical device and a second remote location associated with a caregiverof the patient. The at least one of the first remote location and thesecond remote location can be selected based on data associated with anoperation of the wearable medical device.

Clause 30. The wearable medical device of clause 29, wherein the atleast one of the first remote location and the second remote locationcan be further selected based on data associated with the first remotelocation and data associated with the second remote location.

Clause 31. The wearable medical device of any of clauses 29 and 30,wherein the data can include at least one of data associated with amedical event of the patient detected by the monitoring circuitry anddata associated with a treatment attempted or applied by the wearablemedical device.

Clause 32. The wearable medical device of any of clauses 29 to 31,wherein audio and/or video data can be communicated via the audio and/orvideo communication link, and the communication circuitry can beconfigured to transmit supporting data to the at least one of the firstremote location and the second remote location.

Clause 33. The wearable medical device of any of clauses 29 to 32,wherein the communication circuitry can initiate the audio and/or videocommunication link by placing a call, and the call can be routed to asub-location of the one of the first remote location and the secondremote location based on the supporting data.

Clause 34. The wearable medical device of any of clauses 29 to 33,wherein the data can include technical information relating to thewearable medical device.

Clause 35. The wearable medical device of any of clauses 29 to 34,wherein the data can include technical information associated with oneor more error codes displayed to the patient.

Clause 36. A wearable medical device includes monitoring circuitryoperative for monitoring a cardiac condition of a patient using thewearable medical device; and communication circuitry operative forinitiating an audio and/or video communication link with a remotelocation. The communication circuitry can be configured to transmitsupporting data to the remote location and initiate the audio and/orvideo communication link.

Clause 37. The wearable medical device of clause 36, wherein thecommunication circuitry can be configured to transmit the supportingdata to the remote location contemporaneously or substantiallycontemporaneously with initiating the audio and/or video communicationlink.

Clause 38. The wearable medical device of any of clauses 36 and 37,wherein the communication circuitry can be configured to provide aprompt to a user prior to transmitting the supporting data to the remotelocation.

Clause 39. The wearable medical device of any of clauses 36 to 38,wherein the communication circuitry is further configured to provide aprompt to a user at least one of prior to initiating the audio and/orvideo communication link and prior to transmitting data to the remotelocation over the audio and/or video communication link, and wherein theuser prompt comprises a prompt for user consent to release informationto the remote location.

Clause 40. The wearable medical device of any of clauses 36 to 39,wherein the communication circuitry can be configured to transmit thesupporting data to the remote location after the initiation of the audioand/or video communication link.

Clause 41. The wearable medical device of any of clauses 36 to 40,wherein the supporting data can include data associated with at leastone of the wearable medical device and the patient using the wearablemedical device.

Clause 42. The wearable medical device of any of clauses 36 to 41,wherein the communication circuitry can initiate the audio and/or videocommunication link by placing a call, and the call can be routed to theremote location based on the supporting data.

Clause 43. The wearable medical device of any of clauses 36 to 42,wherein the communication circuitry can transmit the supporting data tothe remote location via another communication link separate from theaudio and/or video communication link.

Clause 44. The wearable medical device of any of clauses 36 to 43,wherein the supporting data can include data collected over a period oftime during which the patient is using the wearable medical device.

Clause 45. A wearable medical device includes monitoring circuitryconfigured to monitor a cardiac condition of a patient using thewearable medical device; and communication circuitry configured toinitiate an audio and/or video communication link with a remotelocation. The remote location can be selected based on a previouscommunication link initiated by the communication circuitry with aprevious remote location.

Clause 46. The wearable medical device of clause 45, wherein the remotelocation can be selected based on a plurality of different previouscommunication links initiated by the communication circuitry with aplurality of different previous remote locations.

Clause 47. The wearable medical device of any of clauses 45 and 46,wherein the remote location can be selected based on data transmitted bythe communication circuitry to the previous remote location.

Clause 48. The wearable medical device of any of clauses 45-47, whereinthe remote location can be selected based on a particular technicalsupport agent associated with the previous remote location.

Clause 49. The wearable medical device of any of clauses 45-48, whereinthe remote location can selected based on data associated with at leastone of the wearable medical device and the patient using the wearablemedical device.

Clause 50. A wearable medical device includes monitoring circuitryconfigured to monitor a cardiac condition of a patient using thewearable medical device; and communication circuitry configured totransmit a message to a remote location. The remote location can beselected based on data associated with at least one of the wearablemedical device and the patient using the wearable medical device.

Clause 51. The wearable medical device of clause 50, wherein the messagecan include a text message.

Clause 52. The wearable medical device of any of clauses 50 and 51,wherein the communication circuitry can be further configured to providea prompt to the patient that requests the patient indicate a nature of acommunication with the remote location.

Clause 53. The wearable medical device of any of clauses 50 to 52,wherein the prompt can include a user interface including a plurality ofdifferent options for indicating the nature of the communication.

Clause 54. The wearable medical device of any of clauses 50 to 53,wherein the remote location can be selected based on the nature of thecommunication.

Clause 55. The wearable medical device of any of clauses 50 to 54,wherein the communication circuitry can be configured to transmit themessage to the remote location, and wherein the remote location isselected based on information included in the message.

Clause 56. The wearable medical device of any of clauses 50 to 55,wherein the communication circuitry can be configured to transmit themessage to the remote location to trigger the remote location to atleast one of transmit another message to the device and initiate acommunication link with the patient based on the data associated with atleast one of the wearable medical device and the patient using thewearable medical device.

Clause 57. The wearable medical device of any of clauses 50-56, whereinthe communication circuitry can be configured to transmit the message tothe remote location to trigger the remote location to transmit themessage based on at least one of the following: a determination ofpatient non-compliance, a detected patient condition, a detected patternof the patient performing an operation incorrectly, a detected abuse ofthe device, a detected performance issue of the device.

Clause 58. The wearable medical device of any of clauses 50 to 57,wherein the communication circuitry can be configured to receive anothermessage from the remote location, wherein the another message includes arequest that the patient indicate a nature of a communication with theremote location.

Clause 59. A wearable medical device including monitoring circuitryconfigured to monitor a cardiac condition of a patient using thewearable medical device; and communication circuitry configured toinitiate a communications link, and communication circuitry configuredto determine a category of data associated with a communication linkfrom a set of data categories, select a remote location from a pluralityof remote locations based on the determined category of the data, andinitiate the communication link to the remote location based on thedetermined category of the data.

Clause 60. The wearable medical device of clause 59, wherein theplurality of remote locations comprise an emergency response location, atechnician location, a physician location, and a relative or caregiverlocation.

Clause 61. The wearable medical device of clauses 59 and 60, wherein thecommunication circuitry is configured to determine the category of thedata as one of monitored physiological data, patient symptom data,location/position data, patient profile and preferences data, treatmentdata, and device parameter data.

Clause 62. The wearable medical device of any of clauses 59 to 61,wherein if the determined category is patient symptom data, thecommunication circuitry is configured to provide the data to thetechnician location for reviewing or editing the data before providingthe data to the physician location.

Clause 63. The wearable medical device of any of clauses 59 to 62,wherein if the determined category is device data, the communicationcircuitry is configured to provide the data to the technician location.

Clause 64. The wearable medical device of any of clauses 59 to 63,wherein if the determined category is treatment data, the communicationcircuitry is configured to provide the data to the relative or caregiverlocation.

Clause 65. The wearable medical device of any of clauses 59 to 64,wherein the communication circuitry is configured to at least one ofprovide the data to the selected remote location and initiate an audioand/or video communication link with the selected remote location.

Clause 66. The wearable medical device of any of clauses 59-65, whereinthe communication circuitry is configured to determine the category ofdata associated with the communication link from the set of datacategories based on user input to the device.

Clause 67. The wearable medical device of any of clauses 59-66, whereinthe communication circuitry is configured to determine the category ofdata associated with the communication link from the set of datacategories based on one or more characteristics of the data.

Clause 68. The wearable medical device of any of clauses 1-33, whereinthe remote location is one of an emergency response location, atechnician location, a physician location, and a relative or caregiverlocation.

Clause 69. The wearable medical device of any of clause 1-33 and 68,wherein the communication circuitry is configured to determine thecategory of the data as one of monitored physiological data, patientsymptom data, location/position data, patient profile and preferencesdata, treatment data, and device parameter data and select one of theemergency response location, the technician location, the physicianlocation, and the relative or caregiver location as the remote locationbased on the determined category of the data.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features and characteristics of the present disclosure,as well as the methods of operation and functions of the relatedelements of structures and the combination of parts and economies ofmanufacture, will become more apparent upon consideration of thefollowing description and the appended claims with reference to theaccompanying drawings, all of which form a part of this specification,wherein like reference numerals designate corresponding parts in thevarious figures. It is to be expressly understood, however, that thedrawings are for the purpose of illustration and description only andare not intended as a definition of the limit of the invention.

FIG. 1 is a schematic drawing of a wearable medical device;

FIG. 2 is a block diagram of an example monitor for a wearable medicaldevice;

FIG. 3 is an example schematic diagram of a wearable medical device;

FIG. 4 is an example block diagram illustrating functional components ofa patient monitor (e.g., a cardiac monitor);

FIG. 5 is an example schematic diagram of a system for communicatingdata;

FIG. 6 is a flow chart illustrating operation of a system forcommunicating data;

FIG. 7 is a flow chart illustrating classification or categorization ofdata;

FIG. 8 illustrates an example user interface of a wearable medicaldevice;

FIG. 9A illustrates another example user interface of a wearable medicaldevice; and

FIG. 9B is an example schematic diagram of a system for interactivecommunications.

DETAILED DESCRIPTION

As used herein, the singular form of “a”, “an”, and “the” include pluralreferents unless the context clearly dictates otherwise.

As used herein, the terms “right”, “left”, “top”, and derivativesthereof shall relate to the invention as it is oriented in the drawingfigures. However, it is to be understood that the invention can assumevarious alternative orientations and, accordingly, such terms are not tobe considered as limiting. Also, it is to be understood that theinvention can assume various alternative variations and stage sequences,except where expressly specified to the contrary. It is also to beunderstood that the specific devices and processes illustrated in theattached drawings, and described in the following specification, areexamples. Hence, specific dimensions and other physical characteristicsrelated to the embodiments disclosed herein are not to be considered aslimiting.

Unless indicated to the contrary, the numerical parameters set forth inthe following specification and attached claims are approximations thatcan vary depending upon the desired properties sought to be obtained bythe present disclosure.

Notwithstanding that the numerical ranges and parameters setting forththe broad scope of the invention are approximations, the numericalvalues set forth in the specific examples are reported as precisely aspossible. Any numerical value, however, inherently contain certainerrors necessarily resulting from the standard deviation found in theirrespective testing measurements.

Also, it should be understood that any numerical range recited herein isintended to include all sub-ranges subsumed therein. For example, arange of “1 to 10” is intended to include any and all sub-ranges betweenand including the recited minimum value of 1 and the recited maximumvalue of 10, that is, all subranges beginning with a minimum value equalto or greater than 1 and ending with a maximum value equal to or lessthan 10, and all subranges in between, e.g., 1 to 6.3, or 5.5 to 10, or2.7 to 6.1.

As used herein, the terms “communication” and “communicate” refer to thereceipt or transfer of one or more signals, messages, commands, or othertype of data. For one unit or component to be in communication withanother unit or component means that the one unit or component is ableto directly or indirectly receive data from and/or transmit data to theother unit or component. This can refer to a direct or indirectconnection that can be wired and/or wireless in nature. Additionally,two units or components can be in communication with each other eventhough the data transmitted can be modified, processed, routed, and thelike, between the first and second unit or component. For example, afirst unit can be in communication with a second unit even though thefirst unit passively receives data, and does not actively transmit datato the second unit. As another example, a first unit can be incommunication with a second unit if an intermediary unit processes datafrom one unit and transmits processed data to the second unit. It willbe appreciated that numerous other arrangements are possible.

This disclosure relates to communication components, modules,subsystems, circuitry and/or techniques for use in external medicaldevices. For example, such communication components, modules,subsystems, circuitry and/or techniques can be used in the context ofmedical devices for monitoring and/or providing treatment to a patient.For example, such medical devices can include monitoring devicesconfigured to monitor a patient for certain conditions. In someimplementations, such devices are capable of, in addition to monitoringfor patient conditions, providing treatment to a patient based ondetecting a predetermined patient condition.

For example, external medical devices as disclosed herein can includecardiac monitoring and/or automated pacing devices or defibrillators,such as, in-facility monitoring defibrillators (e.g., for patients thatare confined to a limited space within a facility, such as, within ahospital environment, to a patient's room) or outpatient wearabledefibrillators or monitors. Such devices can be configured to monitor apatient for an arrhythmia condition such as bradycardia, ventriculartachycardia (VT) or ventricular fibrillation (VF). In addition, whilethe detection methods and systems described hereinafter are disclosed asdetecting VT and VF, this is not to be construed as limiting theinvention as other arrhythmias, such as, but not limited to, atrialarrhythmias such as premature atrial contractions (PACs), multifocalatrial tachycardia, atrial flutter, and atrial fibrillation,supraventricular tachycardia (SVT), junctional arrhythmias, tachycardia,junctional rhythm, junctional tachycardia, premature junctionalcontraction, and ventrical arrhythmias such as premature ventricularcontractions (PVCs) and accelerated idioventricular rhythm, may also bedetected. In the case of treatment devices, such as, pacing and/ordefibrillating devices, if an arrhythmia condition is detected, thedevice can automatically provide a pacing or defibrillation pulse orshock to treat the condition.

External medical devices as disclosed herein can include wearablecardiac monitors and/or defibrillators (which can include pacingfunctionality). Devices described herein as external or non-invasive canbe contrasted with invasive medical devices, such as implantabledefibrillators or implantable pacing devices.

The external medical devices as described herein can include monitoringcircuitry and communication circuitry. The monitoring circuitry canmonitor a patient condition including one or more medical conditions.For example, the monitoring circuitry can, in addition to monitoring forcardiac conditions as described above, monitor for other physiologicalinformation or parameters, such as, without limitation, blood pressure,temperature, blood glucose levels, and blood oxygen levels. In one ormore implementations, monitored physiological information or parameterscan also include, without limitation, patient symptom data (e.g.,patient-reported symptoms and/or automatically detected patientinformation), related cardiac data including premature ventricularcontraction (PVC) count, heart rate information, heart sounds data, ECGdata (e.g., continuous ECG data), lung fluid measurements/data, patientthoracic impedance measurements/data, and pectoral impedancemeasurements/data, and changes in such data. For example, the ECG datacan be associated with the patient symptom data. For example, up to aone minute or more ECG recording can be associated with one or morepatient-reported symptoms as described in further detail below. Forexample, the physiological data may be pre-tagged by the user (e.g., thepatient) prior to transmission. In an example, the patient can input oneor more annotations relating to the physiological information that isthen transmitted along with the physiological information.

In various implementations, the external medical devices as describedherein can be ambulatory, e.g., the device is capable of and designedfor moving with the patient. For example, as described in detail below,the external medical device can be a wearable medical device. In someimplementations, the external medical devices as described herein may bea portable medical device. For example, the device may be capable ofbeing moved from one location to another by, e.g., a user such as anemergency responder or a caregiver.

The devices as described herein may be capable of continuously,substantially continuously, long-term and/or extended use or wear by, orattachment or connection to a patient.

For example, devices as described herein may be capable of being used orworn by, or attached or connected to a patient, without substantialinterruption for a predetermined period of time. In some examples, suchdevices may be capable of being used or worn by, or attached orconnected to a patient for example, up to hours or beyond (e.g., weeks,months, or even years).

In some implementations, such devices may be removed for a period oftime before use, wear, attachment, or connection to the patient isresumed, e.g., to change batteries, to change the garment, and/or totake a shower, without departing from the scope of the examplesdescribed herein.

The devices as described herein may be capable of continuously,substantially continuously, long-term and/or extended monitoring of apatient.

For example, devices as described herein may be capable of providingcardiac monitoring without substantial interruption for a predeterminedperiod of time. In some examples, such devices may be capable ofcontinuously or substantially continuously monitoring a patient forcardiac-related information (e.g., ECG information, including arrhythmiainformation, heart sounds, etc.) and/or non-cardiac information (e.g.,blood oxygen, the patient's temperature, glucose levels, and/or lungsounds), for example, up to hours or beyond (e.g., weeks, months, oreven years).

In some implementations, such devices may be powered down for a periodof time before monitoring is resumed, e.g., to change batteries, tochange the garment, and/or to take a shower, without departing from thescope of the examples described herein.

In some instances, the devices may carry out its monitoring in periodicor aperiodic time intervals or times. For example, the monitoring duringintervals or times can be triggered by a user action or another event.For example, one or more durations between the periodic or aperiodicintervals or times can be user-configurable.

In various implementations, the devices may be operated on battery powerfor a duration of the device's use after which the batteries may bereplaced and/or recharged.

In accordance with an implementation, a medical device can includecommunication circuitry that can initiate an interactive communicationlink, including one or more of an audio and/or video communication link,a text messaging link, such as SMS message or MMS messaging, a real-timechat service, or other live support communication link, with a remotelocation. For example, the remote location can be selected based on dataassociated with at least one of the medical device and the patient usingthe medical device.

In some examples, the communication circuitry can be configured toinitiate the interactive communication link with at least one of a firstremote location for providing technical support for the medical deviceand a second remote location associated with a caregiver of the patient.As noted above, the communication link can be an audio and/or videocommunication link. Further, in some examples, the at least one of thefirst remote location and the second remote location can be selectedbased on data associated with an operation of the medical device. Forexample, one or more remote locations or destinations as describedherein may include computer systems, devices (e.g., desktop computers,handheld devices, smartphones, or tablet computing devices), networks,telephone circuitry and equipment, and/or other communications systemsto facilitate the receiving and sending of information as well as theestablishment of communication links (such as video/audio and/or textualcommunication links) between the medical device 100 and the one or moreremote locations. In some implementations, the one or more remotelocations can include circuitry and/or equipment for recording theinformation transferred over the communication links. For example,audio/video calls and/or textual messages can be recorded and stored forlater review. For example, audio/video conversations may be transcribedinto a text transcript, including images, prior to being stored.

In an example, the communication circuitry can be operative forinitiating an audio and/or video communication link with a remotelocation and configured to also transmit supporting data to the remotelocation via the audio and/or video communication link or a differentcommunication channel. For example, the supporting data can betransmitted prior to, during or substantially during, or subsequent toinitiating and maintaining the communication link.

In another example, the communication circuitry can be configured toinitiate a communication link with a remote location, which is selectedbased on one or more previous communication links initiated by thecommunication circuitry with one or more prior remote locations. In thismanner, the device may consider a history of prior communication linksestablished with a plurality of remote locations in determining anappropriate location with which to establish a link.

In an example and with reference to FIGS. 1 and 4, an external medicaldevice 100 can be configured as a wearable defibrillator 1, such as theLifeVest® wearable defibrillator available from ZOLL® MedicalCorporation of Pittsburgh, Pa. and Chelmsford, Mass. The wearabledefibrillator 1 can be worn by a patient 9 and can include a garment 2(shown in phantom in FIG. 1), an electrode assembly 3, and a monitor 5operatively connected to the electrode assembly 3. The garment 2 can beconfigured as a harness, shirt, or other apparel and is configured topermit the defibrillator 1 to be worn by on about the torso of thepatient 9. The electrode assembly 3 can be configured to be assembledwithin the garment 2.

Such wearable defibrillators may be configured for long term or extendedwear. For example, the wearable defibrillator may be continuously orsubstantially continuously worn by a patient for two to three months ata time. During the period of time in which they are worn by the patient,the wearable defibrillator 1 can be configured to continuously orsubstantially continuously monitor the vital signs of the patient, to beuser-friendly and accessible, to be as light-weight, comfortable, andportable as possible, and to be capable of delivering one or morelife-saving therapeutic shocks when needed. Non-limiting examples ofsuitable wearable defibrillators are disclosed in U.S. Pat. Nos.4,928,690; 5,078,134; 5,741,306; 5,944,669; 6,065,154; 6,253,099;6,280,461; 6,681,003; 8,271,082; and 8,369,944; the entirety of all ofwhich are incorporated by reference herein.

With continued reference to FIG. 1, the electrode assembly 3 includes aplurality of electrodes, such as electrodes 7 a, 7 b, 7 c, and 7 d,which contact a patient 9 when the wearable defibrillator 1 is worn bythe patient 9. According to one example, the electrodes 7 a, 7 b, 7 c,and 7 d are configured to receive electrocardiograph (ECG) signals fromthe patient 9. For instance, the electrodes 7 a, 7 b, 7 c, and 7 d canbe positioned on the patient 9 to receive ECG signals from afront-to-back channel and from a side-to-side channel. For example, thefront-to-back (FB) channel can include one or more of electrodes 7 a, 7b, 7 c, and 7 d positioned on the chest of the patient 9 and another oneor more of the electrodes 7 a, 7 b, 7 c, and 7 d positioned on the backof the patient 9. For example, the side-to-side (SS) channel includesone of the electrodes 7 a, 7 b, 7 c, and 7 d positioned on the left sideof the chest and another one of the electrodes 7 a, 7 b, 7 c, and 7 dpositioned on the right side of the chest of the patient 9. In someexamples, the electrodes 7 a, 7 b, 7 c, and 7 d can be operativelyconnected to a distribution node 11 of the electrode assembly 3.

In some implementations, the electrode assembly 3 can also comprisetherapy pads 13 a, 13 b, and 13 c operatively connected to thedistribution node 11. The therapy pads 13 a, 13 b, and 13 c can beconfigured to deliver one or more life-saving therapeutic shocks whenneeded. In some examples, the electrode assembly 3 can also includeother sensing electrodes and devices (not shown) such as, but notlimited to, heart beat sensors, accelerometers, and sensors capable ofmeasuring blood pressure, heart rate, thoracic impedance, respirationrate, heart sounds, acoustic sensors, audio transducers, and theactivity level of the subject. The electrode assembly 3 can furthercomprise a tactile stimulator 12, such as a vibrator, positioned withinthe distribution node 11 to provide tactile stimulation to the patient 9as described in greater detail hereinafter.

The monitor 5 can be operatively connected to one or more of the therapypads 13 a, 13 b, and 13 c and electrodes 7 a, 7 b, 7 c, and 7 d via atrunk cable 15 or any other suitable cable or connection device. Wiringor other connection devices can be used to connect at least one portionof the distribution node 11 to the electrodes 7 a, 7 b, 7 c, and 7 d andtherapy pads 13 a, 13 b, and 13 c. Alternatively, the monitor 5 can beoperatively connected to one or more of the electrodes 7 a, 7 b, 7 c,and 7 d, therapy pads 13 a, 13 b, and 13 c, and distribution node 11 bya wireless connection or a combination of wireless and wiredconnections.

The distribution node 11 is configured to obtain ECG data from theelectrodes 7 a, 7 b, 7 c, and 7 d, digitize this data, and transfer thisdata to the monitor 5. Accordingly, the distribution node 11 includes aprocessor, such as a belt node processor (BNP) 17 (see FIGS. 3, 4A, and4B), operatively connected to electrodes 7 a, 7 b, 7 c, and 7 d andconfigured to receive signals representing the ECG of the patient 9 fromthe electrodes 7 a, 7 b, 7 c, and 7 d. The BNP 17 communicates with themonitor 5 via a Controller Area Network (CAN) bus 19 (see FIGS. 3, 4A,and 4B) or any other suitable bus that comprises trunk cable 15. The BNP17 is also configured to sense whether one or more of electrodes 7 a, 7b, 7 c, and 7 d have fallen off the patient's body, to control thetactile stimulator 12, and to fire the electrode gel interface forproviding electrolytic gel 14 (FIG. 1) to the therapy pads 13 a, 13 b,and 13 c when a request is received from the monitor 5.

With reference to FIG. 2, and with continuing reference to FIG. 1, themonitor 5 can include an external housing 31 having a port 38 to whichthe ECG electrodes 7 a, 7 b, 7 c, and 7 d and therapy pads 13 a, 13 b,and 13 c of the electrode assembly 3 are operatively coupled to themonitor 5 via the trunk cable 15. The external housing 31 furthercomprises at least one, and for example, a pair of patient responsebuttons 41 positioned, for example, in the top left corner of thehousing 31. The external housing 31 of the monitor 5 can also include adisplay screen 43 for providing information to the patient 9 and forproviding a user input device to the patient 9. In other embodiments,visual indicators 25, such as LED bulbs, can be positioned on thehousing 31 for providing information to the patient 9. The externalhousing 31 can include an audio system having a speaker 21 and amicrophone 23 positioned on the external housing 31. The speaker 21 isdesirably positioned at least 2.5 inches away from the microphone 23 tominimize feedback. As will be discussed herein, the display screen 43,visual indicators 25, and speaker 21 can be used for providing feedbackand/or alerts to the patient 9.

Further details of the monitor 5 can be found in U.S. patent applicationSer. No. 14/448,997, which is hereby incorporated by reference in itsentirety.

In some implementations, the medical device as described herein can be ahospital-based wearable defibrillator and/or pacing device. For example,such a hospital-based device can include a defibrillator and/or pacingdevice configured for continuous or substantially continuous use, wear,connection, attachment, or monitoring to/of a patient in a hospitalenvironment. The hospital-based device can include a plurality oftherapy and sensing electrodes that are attached to the patient's skin.In some examples, the electrodes are disposable adhesive electrodes. Insome implementations, the electrodes are affixed to an electrodeassembly (a patch), which can then be adhesively attached to thepatient's skin. The electrodes can be attached to the patient's skin atparticular locations as prescribed by a trained professional.

In operation, the hospital-based device can include a monitor configuredto operate in a manner that is different from that of the monitor ofwearable defibrillator 1 described above with respect to FIG. 1. Asdescribed in more detail herein, an interface, prompts, andcommunication performed by the hospital-based device can be configuredfor and/or directed to a user other than the patient 9, e.g., acaregiver such as a nurse or a patient service representative. Forexample, a caregiver can program the device and/or set the device up foruse by the patient 9. The interface, prompts, and communication can bedirected to the patient 9 in scenarios such as when a response isrequired to let the device know whether or not the patient 9 isconscious, which can be used in deciding when to shock the patient 9,and when a patient is given an alert to call the caregiver.

In some implementations, the medical device as described herein can be ashort-term medical device. For example, such a short-term medical devicecan include a defibrillator and/or pacing device configured forcontinuous or substantially continuous use, wear, connection,attachment, or monitoring to/of a patient for a shorter period of timethan a long term wearable defibrillator (e.g., up to days, weeks, ormonths as deemed medically necessary). For example, such a short-termdefibrillator can be configured to monitor a patient presenting withsyncope (e.g., by analyzing the patient's cardiac activity for aberrantpatterns that can indicate abnormal physiological function). In someexamples, aberrant patterns may occur prior to, during, or after theonset of syncope symptoms. For example, the short-term outpatientdefibrillator can include a plurality of electrodes and/or an electrodeassembly (patch) that can be adhesively attached to the patient's skin.The patient may replace the electrodes and/or patches as prescribed. Theelectrodes can be positioned in a configuration similar to that of thehospital-based device described above.

As noted above, a wearable medical device can be used for a wide rangeof patient conditions or situations, including following a recentmyocardial infarction or coronary revascularization. In some examples,the wearable medical device can give caregivers time to optimize medicaltherapy and assess a patient's long-term risk for sudden death. In someexamples, the wearable medical device is configured to continuouslymonitor the patient's heart and, if a life-threatening heart rhythm isdetected, the device can issue an alert to the patient. For example, thewearable medical device can include a user interface for interactingwith the wearable medical device. The wearable medical device can alsoinclude one or more input mechanisms (e.g., buttons, soft keys, etc.)that the patient can interact with in order to respond to a treatmentalert. In some examples, the wearable medical device issues a treatmentalert before providing a treatment shock, and if the patient does notrespond to the treatment alert (e.g., by touching, pressing or holdingdown one or more response buttons, soft keys, etc.), the wearablemedical device can deliver the treatment shock to restore normal heartrhythm.

With reference to FIG. 3 and with continuing reference to FIGS. 1 and 2,the functional components of the monitor 5 can be provided within theexternal housing 31 of the monitor 5. In one example, the functionalcomponents of monitor 5 can be provided on a distributed printed circuitboard as disclosed in U.S. patent application Ser. No. 14/448,857, whichis hereby incorporated by reference in its entirety. In one example, thefunctional components of monitor 5 can comprise a discharge module 42,an energy storage module 44, a controller 46, and a communication module48. The discharge module 42 is for selectively delivering an energypulse to the patient 9 via therapy electrodes 13 a, 13 b, and 13 c. Theenergy storage module 44 can be operatively connected to the dischargemodule 42. The controller 46 can be operatively connected to the energystorage module 44 and can be configured to control the delivery of theenergy pulse to the patient 9. The communication module 48 can beoperatively connected to the controller 46.

In one example, the energy storage module 44 can include a high voltagepower convertor 64 (shown in FIG. 3) and a capacitive device, such as abank of capacitors 67 (shown in FIG. 3). The monitor can comprise abattery pack (not shown), which provides power to the monitor 5 and/orwearable defibrillator 1. The discharge module 42 can include at leastone high-voltage switch and can be configured to selectively deliver anenergy pulse stored in the energy storage module 44 to the patient 9based on a signal from the controller 46. The energy pulse is sent fromthe discharge module 42 through the port 38 to the patient 9 via therapypads 13 a, 13 b, and 13 c.

A biphasic waveform can be delivered to the patient 9 by switching theat least one high voltage switch of the discharge module 42. Theoperation of the pulse delivery system can be dynamic and depend on thepatient's body impedance while the pulse is being delivered. Forexample, an amount of energy delivered can be held constant whilevarying the duration of the first phase and the second phase. In anotherexample, a monophasic waveform can be delivered to the patient dependingon the patient's condition or a condition of energy storage module 44.

With reference to FIG. 3, and with continuing reference to FIGS. 1 and2, controller 46 can include one or more processors, each of whichoperates under the control of a control program that executes at runtimefor performing certain functions of the medical device, e.g., wearabledefibrillator 1.

Also or alternatively to the one or more processors, controller 46 caninclude discrete and/or integrated electrical and/or electroniccircuitry that is configured to perform the functions described herein(either alone or in combination with one or more of processors), with orwithout a control program. In an example, the electrical and/orelectronic circuitry of controller 46 can include one or more discreteelements, such as, without limitation, one or more of the followingdiscrete elements: transistor, resistor, capacitor, inductor, memristor,diode, loudspeaker, buzzer, linear variable differential transformer(LVDT), rotary encoder, shaft encoder, inclinometer, motion sensor,vibration sensor, flow meter, strain gauge, accelerometer, thermocouple,thermopile, thermistor, resistance temperature detector (RTD),bolometer, thermal cutoff, magnetometer, gauss meter, hygrometer, photoresistor, LED or other light emitting device, and/or antenna.

In another example, the electrical and/or electronic circuitry ofcontroller 46 can also or alternatively include one or more integratedcircuits, such as, without limitation, analog integrated circuit,digital integrated circuit, mixed signal (analog and digital) integratedcircuit, application specific integrated circuit (ASIC), programmablelogic device (PLD), gate array, field programmable gate array (FPGA),and/or microelectromechanical systems (MEMS). In an example, these oneor more integrated circuits can include one or more of analog-to-digitalconverter (ADC), a multiplexer, a power regulator, or some combinationthereof.

In another example, controller 46 is operatively connected to a userinterface 70 (comprised of one or more response buttons 41 and/ordisplay screen 43), the high voltage power convertor 64, and thedischarge module 42. Such configuration allows controller 46 to provideoutput to a patient 9, for example through the display screen 43 and/orspeaker 21, and accept input from the patient 9, for example fromresponse buttons 41 and/or display screen 43 when configured as a touchscreen, as well as provide instructions to the high voltage powerconverter 64 and/or the discharge module 42 to deliver a therapeuticshock to the patient 9. For example, controller 46 can be used toprovide certain functions within the wearable defibrillator 1 such as,but not limited to: high voltage converter control; discharge modulecontrol; real time clock (RTC) 34 (Date/time) for the system; executionof timing-critical software or functions such as therapy pulsesynchronization (e.g., synchronizing the pulse delivery to avoiddelivering a pulse on a T wave); ECG acquisition from the CAN bus 19;ECG monitoring and arrhythmia detection; user interface control;treatment sequencing; audio message generation; and data communicationsand storage. An example of the methods used to detect abnormal heartrhythms can be found in U.S. Pat. No. 5,944,669, which is assigned tothe assignee of the present application and which is hereby incorporatedby reference in its entirety.

In some implementations, the BNP 17 can be operatively connected to thecontroller 46. The BNP 17 can act as an ECG data acquisition engine forthe controller 46 via the CAN bus 19 as described hereinabove.

In an example, the communication module 48 can be controlled bycontroller 46 and can provide one or more communication devices forcommunicating information to and from the monitor 5. For example, thecommunication module 48 can include one or more communication devices,such as, without limitation, a GPS transceiver, a Bluetooth transceiver,a Wi-Fi modem, and/or a cellular modem. The communication module 48 isconfigured to communicate with a remote server 78 and/or other remotelocations via one or more communication devices, e.g., the cellularmodem. The communication module 48 can also communicate with the remoteserver 78 and/or the other remote locations via another communicationdevice, e.g., the Wi-Fi modem. For example, if the communicationcapabilities of one of the communication devices is not available (e.g.,the cellular communications capabilities), the communications module 48can communicate with the remote server 78 via one of the othercommunication devices.

In an example, the user interface 70 can provide one or more “call”buttons 53 (or one or more of the response buttons 41 can be configuredas a “call” button) that accept input from a user (e.g., the patient 9)when the user actuates the call button 53. For example, thecommunications module 48 can be controlled by the controller 46 toinitiate an audio and/or video communication link with a remote locationin response to actuation of the “call” button 53. In an implementation,the display screen 43 can display the “call” button 53 as an iconselectable by the patient 9 via the user interface provided by thedisplay screen 43 and which controls the communications module 48 tocall the remote location. In some examples, the user can initiate thecommunication link through other techniques known in the art. Forinstance, the user may initiate the communication link by speak a voicecommand, e.g., “Call Service,” or “Call Operator.”

For the purpose of simplicity, references hereinafter will be made tomonitor 5 shown in FIGS. 1, 3A and 4 that includes controller 46.However, this is not to be construed as limiting the invention since itis envisioned that controller 46 can include any suitable and/ordesirably combination processor(s) and/or circuitry.

It should be appreciated that in various implementations, thecommunication link(s) described herein can be initiated and/ormaintained without materially affecting other functions of the medicaldevice, including, the monitoring, alerting, and/or treating aspects ofthe device.

In another example and with reference to FIG. 4, it is envisioned thatthe external medical device 100 as described herein can include a mobilepatient monitor, for example, a cardiac monitor. As such, communicationsdescribed herein can also be used in connection with the patient monitor300. The monitor 300 can include a controller 302 that iscommunicatively coupled (e.g., wired or wirelessly coupled) to receivefrom sensors and/or electrodes 7 a-7 d appropriately positioned onpatient 9 signals (e.g., ECG data and/or heart sounds data from anacoustic sensor) indicative of cardiac activity of patient 9. In someexamples, the sensors and/or electrodes can be an integral part of thehousing structure of the patient monitor.

In some examples, the patient monitor 300 can be a cardiac monitorconfigured to receive cardiac data (e.g., ECG data and/or heart soundsdata from an acoustic sensor). In some examples, the patient monitor 300can, in addition to cardiac monitoring, perform monitoring of otherrelevant patient physiological information and/or parameters, e.g.,glucose levels, blood oxygen levels, lung fluids, lung sounds, and bloodpressure. In some examples, the patient monitor 300 can include motionsensors to track patient movement. For example, the patient monitor 300can be in the form of an application on a handheld device, such as, asmartphone, a personal digital assistant, or a tablet device. In suchimplementations, the communication techniques described herein can beused in connection with monitoring the battery life status of thebattery of the smartphone, personal digital assistant, or tablet device.

As shown, the patient monitor 300 can communicate with a remote server78 or other remote location (e.g., one or more computer systems). Forexample, the patient monitor 300 may communicate with another device,which may be a remote handheld device (e.g., a smartphone, a personaldigital assistant, or a tablet device). For example, the patient monitor300 may periodically (e.g., on a preset schedule) and/or aperiodically(e.g., when prompted by an operator) establish a wireless communication(e.g., cellular communication, Wi-Fi or Bluetooth) to transfer patientdata to the remote server 78.

In an example, patient monitor 300 can include a user interface 304, acommunications module 306 and a battery monitoring circuit 308 coupledto controller 302. A main battery 310 and an optional backup battery 312can be used to supply electrical power for the operation of controller302, user interface 304, communications module 306 and batterymonitoring circuit 308. Main battery 310 can be a rechargeable batterythat is received in a battery receptacle 314 of patient monitor 300.Optional backup battery 312 can be a rechargeable battery or a singleuse battery.

In an example, the communication module 306 includes similarcommunication devices and operates in a similar manner as describedabove in connection with communication module 48. For example, the userinterface 304 can provide one or more “call” buttons 53 that acceptinput from a user (e.g., the patient 9) when the user actuates the callbutton 53.

In an example and with reference to FIGS. 5 and 6, the external medicaldevice 100 receives data associated with the external medical device 100and/or the patient 9 using the external medical device 100 at stage 700.The external medical device 100 can sense or collect the data and/orreceive the data from one or more remote data sources. The remote datasources can include the remote server 78, remote locations A, B, . . .N, and/or another remote location, such as, a remote database 600 thatstores patient data associated with patients that have been assignedexternal medical devices and/or device data associated with the externalmedical devices assigned to the patients.

The data received and/or sensed by the external medical device 100 caninclude physiological data of the patient 9 (e.g., ECG data from theelectrodes 7 a-7 d and/or other data from other devices or sensors, suchas, but not limited to, heart beat sensors, accelerometers, and sensorscapable of measuring blood pressure, heart rate, glucose levels, bloodoxygen levels, thoracic impedance, respiration rate, lung fluids, sleepdata, heart and/or lung sounds, acoustics, audio, and/or the activitylevel of the subject), data indicating a change in a physiologicalcondition of the patient 9, data indicating a stress level of thepatient 9, patient symptoms (e.g., shortness of breath, lightheadedness, racing heart, skipped beat, fatigue, fainting, chestdiscomfort, and other symptoms, patient activity level (e.g., resting,light activity, moderate activity, and rigorous activity), demographicdata of the patient (e.g., a name, medical history, insuranceinformation, age, weight, sex, and/or other identifying information ofthe patient), a preference of the patient for a particular remotelocation (e.g., a patient selected hospital and/or a location associatedwith a patient selected doctor), operation data associated with anoperation of the external medical device 100 (e.g., recent systemactivity and/or diagnostics, error codes, battery status, and/orcommunications status or availability), a location of the externalmedical device 100 (e.g., a GPS coordinates of the device), a locationof the external medical device 100 with respect to the remote location(e.g., a distance of the device 100 from the remote location via GPScoordinates and/or a mapped route), a reason for initiating thecommunication link (e.g., a technical issue with the device 100, suchas, an error code or patient requesting help regarding operation of thedevice 100, and/or a medical event of the patient), a languagepreference of the patient, a priority level of the communication link(e.g., a time from and/or severity of a prior medical event of thepatient, a time from a prior treatment applied by the device 100, and/ora type of error code or malfunction), a treatment event of the externalmedical device 100 (e.g., a shock applied by the device 100 the patientand/or an attempted treatment canceled by the patient or aborted by thedevice 100), a detected cardiac event of the patient (e.g., a detectedcardiac arrhythmia, such as, ventricular fibrillation or ventriculartachycardia), a type of the external medical device 100 (e.g., a modeltype and/or a software version), battery data on a battery of theexternal medical device 100 (e.g., battery level and/chargingefficiency), a technical issue associated with the external medicaldevice 100 (e.g., a specific error code and/or a specific malfunctioningcomponent of the device 100), a representative who assigned the externalmedical device 100 to the patient, a caregiver associated with thepatient (e.g., a doctor and/or a family member), and/or a type ofinsurance associated with the patient. With respect to sleep data, thedevice 100 may receive and/or sense information relating to sleep apnea,an indication of a time when the patient goes to sleep, and/or sleepdata covering a period of time during which the patient is asleep suchas ECG data, heart and lung sounds, respiration, etc.

In some examples, the data summarized above can be grouped into aplurality of categories and/or lists. For example, as shown in FIG. 7,such categories and/or lists can include monitored physiological data750, patient symptom data 752, location/position data 754, patientprofile and preferences data 756, treatment data 758, and deviceparameter data 760, among others. The device 100 can group the data intothe plurality of categories and/or lists when the data is received,determined, or created, e.g., when the device 100 receives or senses thedata, or in response to one or more actions or operations performed bythe device 100 that result in the creation, modification, or use of thedata. The device 100 can analyze the data to determine a category inwhich to classify the data based on the contents of the data itself,associations of the data with other data or operations of the device100, and/or input from a user.

In some implementations, one or more categories can includesubcategories and/or sublists for further classifying the data. In someimplementations, the data and/or events can be preset such that theybelong to default categories, lists, subcategories, or sublists, and maybe modified by a user via a user interface. In some instances, a user(e.g., patient, patient service representative, or a caregiver) may adda new data/event item and accord it to one of an existing or a newuser-defined category, list, subcategory, or sublist.

One or more of the above categories, lists, subcategories, and sublistscan be associated with one or more remote locations (e.g., caregiver'slocation/office, service technician's location/office, or a patient'srelative or loved one). In some implementations, one or more of thecategories, lists, subcategories, and sublists may be associated withone or more actions to be taken on detecting data belonging to thecategories, lists, subcategories, and/or sublists.

In an example, the device 100 can be configured to determine dataassociated with a communication link (e.g., by automatically collectingthe data based on a detected patient or device event, or through patientinput as described in detail below), determine a category (e.g.,including subcategories) in which to classify the data based on one ormore predetermined or user-defined categories, and select a remotelocation from a plurality of remote locations based on the determinedcategory. For example, the device 100 can determine the category inwhich to classify the data based on user input as described in furtherdetail below. For example, the device can determine the category inwhich to classify the data based on one or more characteristics of thedata.

For instance, if the device 100 has recently encountered an error, andthe user (e.g., patient 9) initiates a communication link, the device100 may automatically collect information about the error code, andassociated device error information and based on the characteristics ofthis data as being related to the device, classify the data as devicedata 760. The user then has the ability to confirm the purpose of thecommunication link as being related to the device data 760 and be routedto a technician to discuss the issue.

For example, as shown in FIG. 7, in scenario 770 a, the device 100 canclassify the data associated with the communication link as treatmentdata 758, in scenario 770 b, the device 100 can classify the dataassociated with the communication link as device data 760, or inscenario 770 c, the device 100 can classify the data associated with thecommunication link as patient symptom data 752. In some implementations,the device 100 can provide the data associated with the communicationlink to the selected remote location and/or initiate a communicationlink with the selected remote location based on the data category.

For example, the monitored physiological data category or list 750 caninclude information relating to a monitored physiological condition ofthe patient including data indicating an activity level of the patient,monitored ECG data, heart sounds, lung sounds, monitored tissue and/orlung fluids, blood pressure, heart rate, glucose levels, blood oxygenlevels, thoracic impedance, respiration rate, sleep data, acoustics,data indicating stress levels of the patient 9, and data indicating achange in any of the monitored physiological conditions, among others.In some examples, the monitored physiological data category 750 caninclude one or more subcategories or sublists of heart-related data(e.g., ECG, heart sounds, etc.), activity related data (e.g., heartrate, activity level data, etc.), sleep-related data (e.g., time whenpatient goes to sleep, respiration or breathing data, etc.), amongothers.

For example, patient symptom data 752 can include shortness of breath,light headedness, racing heart, skipped beat, fatigue, fainting, chestdiscomfort, and other symptoms. For example, such patient symptom datamay be recorded by a caregiver, the patient, or other user asappropriate in the circumstances.

For example, location/position data 754 can include details relating apatient's location including GPS coordinates, address of location,location within a building or a home, position (standing, laying down,etc.), and altitude from a reference level, among others.

For example, patient profile and preference data 756 can include one ormore patient profile and preferences information including demographicsinformation (age, gender, medical history, etc.), a language preferenceof the patient, a reason for selecting the communication link, dataindicating a representative who assigned the patient the wearablemedical device, a primary care physician or other caregiver assigned tothe patient, insurance data, among others.

For example, treatment data 758 can include, in the context of atreatment device, information relating to a treatment event of awearable medical device, including treatment for a detected cardiacevent of the patient (e.g., a detected cardiac arrhythmia, such asventricular fibrillation or ventricular tachycardia), and treatmentparameters (e.g., number of shocks, voltage, related ECG data, etc.),among others.

For example, device parameter data 760 can include, among others, abattery level of a battery pack of the device, a unique deviceidentifier, device type, device technical history (e.g., prior reportedconditions, prior service information), and technical data associatedwith a reported technical issue of the device (e.g., a specific errorcode and/or a specific malfunctioning component of the device 100).

The external medical device 100 can receive, sense, and/or collect thedata associated with the external medical device 100 and/or the patient9 using the external medical device 100 in periodic or aperiodic timeintervals or times, in dynamic time intervals or times, and/or in acontinuous or substantially continuous manner. For example, the timesduring which the data collection occurs can be triggered by auser-initiated action and/or other event. For example, such times can beuser configurable. In one example, the external medical device 100 cancontinuously or substantially continuously collect the data over aperiod of time during which the patient 9 is associated with theexternal medical device 100. Accordingly, the collected data may providea timeline of data on the device 100, the patient 9, and/or theenvironment of the patient 9 during the time period. For example, theexternal medical device 100 can continuously or substantiallycontinuously monitor the cardiac condition, e.g., an ECG signal, of thepatient 9 during the period of time during which the patient iscontinuously or substantially continuously wearing or using the externalmedical device 100.

In another example, the external medical device 100 can receive, sense,and/or collect the data in response to a user instruction. For example,a caregiver may instruct the device 100 to record an ECG of the patientfor a period of time or the patient 9 may instruct the device to beginrecording the ECG, e.g., when the patient is experiencing a particularsymptom.

For example, the patient can be provided with a drop down menu or checklist that allows the patient to select a particular symptom from a listof options. Options for patient systems can include one or more of:feeling a skipped beat, shortness of breath, light headedness, racingheart rate, fatigue, fainting, chest discomfort, weakness, dizziness,and/or giddiness. Once the patient symptom is selected, the patient canidentify his or her level of physical activity when the symptom wasexperienced. The patient can select a level of activity from a listincluding options, such as, resting, light activity, moderate activity,or rigorous activity. Once the activity level is selected, the user caninitiate a data transmission from the device 100 to the remote server 78and including relevant physiological information by, for example,selecting a “Submit” button.

In the context of a patient-initiated data transmission, for example, inresponse to the selection by the patient, the device 100 can capture aportion of the physiological signal for a period of time when thesymptom was experienced (e.g., in the case of an ECG signal, such aportion can be in the form of an ECG strip). The device 100 canestablish communication with the network, and send the captured portionof physiological information to the remote server 78. For example, acaptured ECG stream can be a strip of about less than a minute. Forexample, a captured ECG strip that is associated with the symptominformation can have a duration of approximately one minute. In somecases, the ECG strip can have a duration that is appropriate for thesymptom(s) reported by the patient and/or event detected by the device100. In some situations, it may be appropriate for the ECG striprecording to be of a duration lasting up to an hour (e.g., in the eventof a recorded atrial flutter).

In some implementations, the patient monitor 20 can continuously recordECG data, and, at the same time, also record an ECG strip relating toone or more events of interest (e.g., patient-reported symptoms). Assuch, if a physician wishes to view ECG data for a period of time priorto or after the recorded ECG strip relating to an event of interest,such data is available for review from the continuously recorded ECGdata stream.

Still referring to FIG. 7, in an example scenario 775 a, if the device100 automatically initiates a communication link in response to thepatient 9 receiving a treatment from the device 100 (e.g., a treatmentfor a cardiac arrhythmia event), the device 100 can automatically detectand classify the information associated with the communication link asbeing related to the treatment. For example, the device 100 may detectand classify the data associated with the communication link asbelonging to the treatment data category 758 based on the detectedcardiac arrhythmia event and one or more treatment parameters, such as,a number of shocks, voltage, related ECG data, etc. Based on thecommunication link (e.g., classification of the data associated with thecommunication link as treatment data), the device 100 can select aremote location from a plurality of remote locations and initiate acommunication link and/or provide the data to the selected remotelocation. For example, the data classified as treatment data 758 can bedirectly provided to a physician, caregiver, and/or other designatedperson.

In scenario 775 b, if the patient 9 initiates a communication link toreport a device error, e.g., a battery error, the device 100 can promptthe patient to input a reason for the communication link as described infurther detail below. In some implementations, the device 100 canautomatically detect the device error event (e.g., based on a deviceerror code) and collect associated data relating to the event. Based onthe communication link (e.g., either or both the patient's input andcollected data associated with the communication link), the device 100can then classify the data as belonging to the device data 760 category.For example, based on the classification of the data associated with thecommunication link as device data, the device can select a remotelocation from a plurality of remote locations and initiate acommunication link and/or provide the data to the selected remotelocation. For example, the data classified as device data 760 can beprovided to a technician location for analysis and troubleshooting thedevice error event.

In scenario 775 c, if the patient 9 causes the device 100 to initiate acommunication link to discuss a symptom, e.g., shortness of breath, thedevice 100 can classify this information as patient symptom data 752and, based on the communication link (e.g., classification of data aspatient symptom data 752), can select a remote location from a pluralityof remote locations and initiate a communication link and/or provide thedata to the selected remote location. In an implementation, the patient9 can be provided with a screen before the link is initiated so that heor she can select the reason for the communication link as being apatient-reported symptom. In some instances, after the patient 9 reportsthe symptom or if the device 100 detects the symptom (e.g., based on thepatient's respiration pattern), the communication link can beautomatically initiated.

For example, the patient symptom data 752 relating to the shortness ofbreath can be provided to a technician location for reviewing or editingthe data before providing the data in a report to a physician location.For example, the patient symptom data 752 can include an ECG strip orrecording associated with the shortness of breath event. In someinstances, the patient symptom data 752 can be directly sent to thephysician or caregiver (or his or her designee). In someimplementations, the device 100 can sent a notification directly to thephysician or caregiver that a patient-initiated symptom has beenrecorded, and also send the patient symptom data 752 to a technician forgenerating a report to the physician or caregiver.

In some implementations, the patient 9 and/or user of device 100 can beafforded an opportunity to select one or more remote locations asdestinations with which one or more communication links is to beestablished. For example, after a treatment is delivered in accordancewith scenario 775 a, the device 100 may prompt the patient 9 to select aremote location immediately after treatment is delivered. For example,in some instances, the patient 9 may opt call his physician's office. Inother instances, the patient 9 may choose to place an emergency servicescall to an emergency services location (e.g., “911 call”) directly fromthe device 100 to summon help from a rescue squad. In yet othersituations, the patient 9 may opt to initiate a conference callincluding both his or her physician's office and a loved one.

In an implementation, the device 100 can initiate a communication linkwith the patient's relative (e.g., by dialing the relative's phonenumber). The device 100 can also automatically sent a notificationmessage (e.g., text or audio) to the patient's physician notifying thephysician about the treatment event and/r providing data relating to thetreatment event.

In some implementations, prior to initiation, after initiation, orduring a communication link, the device 100 can automatically receive,collect, and/or transmit (or the patient 9 can be prompted to provide)additional information needed for assisting the patient 9. For example,if the patient 9 (or technician) has initiated a communication linkbetween the patient 9 and the technician to discuss a battery relatederror, and the technician wishes to learn about the last time the devicecarried out a self-test of the charging system, the device 100 can beconfigured to send this additional information. The device 100 can groupthe data for this additional information into the plurality ofcategories and/or lists based on the communication link and/or the dataitself. For example, data for additional information related to thebattery related error can be group into the device data category 760 andtransmitted to the technician.

In an example, the external medical device 100 can automatically beginto receive, sense, and/or collect the data in response to a particulartime and/or based on previously recorded data. For example, dataindicating a technical issue or medical event that occurred at aparticular time of day and/or with respect to a particular operation ofthe device 100 can cause the device 100 to automatically being tocollect the data when that particular time of day and/or medical eventoccurs again. In some examples, the external medical device 100 canmonitor some parameters of the patient 9 and/or the device 100 and,based on the monitored parameters, determine additional parameters ofthe patient 9 and the device 100 to begin monitoring.

In another example, the patient may be provided with one or morerequirements for wearing or using the external medical device 100, e.g.,that the device 100 must be worn for a certain duration during aparticular time period and/or at specific times of the day or week. Theexternal medical device 100 can monitor a compliance of the patient withthe requirement for wearing or using the external medical device 100during the time period and generate data indicating the compliance ofthe patient. The external medical device 100 can monitor a compliance ofthe patient with the requirement for performing one or more devicerelated or guided activities (e.g., six-minute walk tests) and generatedata indicating the compliance of the patient. Compliance data can betransmitted to one or more remote locations over one or morecommunication links. The patient and/or other user can discuss thecompliance data with a caregiver or support person over the one or morecommunication links.

The external medical device 100 can monitor patient training andgenerate data relating to the training for use in the communication link(e.g., the patient and/or other user can discuss the details of thepatient training with a caregiver or support person).

In an example and with continued reference to FIGS. 5 and 6, theexternal medical device 100 can, at stage 702, automatically initiate orbegin a process to initiate a communication link with one or more of theremote locations A, B, . . . N based on the above-described data and/oranalysis performed in connection with the external medical device 100and/or the patient 9. The external medical device 100 may process thedata, e.g., against one or more rules, and automatically initiate acommunication link(s) with a remote location(s) if the data satisfiesthe one or more rules. For example, the external medical device 100 mayautomatically initiate a communication link with a medical professional,a hospital, and/or a close relative if a predetermined patient conditionoccurs, e.g., the ECG data of the patient indicates a possible cardiacarrhythmia. The device 100 may automatically initiate a communicationlink after the patient has responded to a possible arrhythmia conditionby pressing the response button or after the patient has been treated.

Similarly, the device 100 may automatically initiate the communicationlink in response to detecting an incorrect assembly for the garment(e.g., detecting that one or more electrodes have been incorrectlyinserted into one or more pockets of the garment). In another example,if the device 100 detects a device abuse event or indication, e.g., thedevice 100 suffers an impact exceeding a threshold amount, the devicemay automatically initiate the communication link. For example, thedevice 100 may include an Equipment Abuse Notification as described inU.S. Pat. No. 8,676,313 titled “Wearable medical treatment device withmotion/position detection,” which is hereby incorporated by reference inits entirety. If certain mechanical conditions that may lead toequipment damage such as mechanical shock or vibration are detected byaccelerometers in the device 100 then device 100 can notify the user ofsuch conditions and advise the user by the monitor computer screen.Similarly, if the monitor or belt is dropped or if they are hit withsome other object causing a force greater than a predefined acceptableforce, then the device 100 can provide either an audio or visual(display) indication to the patient that the event has occurred and warnagainst allowing such an event to occur again. If continuous vibrationabove a certain predefined acceptable threshold is detected for a periodof time then the monitor may also provide a warning to the patient. Suchvibration could lead to electrode or therapy pad fall-off or even causefalse arrhythmia detection if enough physical motion is applied to theelectrode and cables.

In addition, the device 100 may either automatically initiate or promptthe user with a screen indicating that the user, if he wishes, mayinitiate the communication link. In some examples, the device 100 canautomatically record the device abuse information and transmit theinformation to a remote location via a communication link. For example,the communication link may not be immediately initiated following thedevice abuse event, but the device abuse information may be stored on amemory of the device 100 and communicated to a remote location at alater time during another communication link.

In some examples, the device 100 may apply one or more predictivealgorithms to the measured physiological information to provide anestimation or prediction for occurrence of a potential medical event fora subject within an associated period of time. The estimation orprediction can be provided in the form of a risk score which can bebased on, for example, physiological measurements extracted from the ECGsignal including heart rate variability, PVC burden or counts, activity,noise quantifications, atrial fibrillation, momentary pauses, heart rateturbulence, QRS height, QRS width, changes in the size or shape of themorphology, cosine R-T, artificial pacing, corrected QT interval, QTvariability, T wave width, T wave alternans, T-wave variability, STsegment changes, early repolarization, late potentials, fractionatedQRS, or fractionated T wave content. The risk score can indicate, forexample, that a patient's condition is generally improving, worsening,or remaining stable. Further, risk score values can be used to determinewhether to automatically initiate the communication link or suggest tothe patient and/or a bystander or a relative to call the patient'scaregiver or an emergency response center.

In another example, the external medical device may automaticallyinitiate a communication link with a technical support center if aparticular error code or technical information relating the device 100is received.

In another example, the external medical device 100 can initiate orbegin a process to initiate a communication link with one or more of theremote locations A, B, . . . N in response to a user instruction atstage 704. As described herein with reference to FIG. 2, the user, e.g.,the patient 9, caregiver, a patient service representative, a bystander,etc., can actuate a “call” button 53 to call one or more remotelocations associated with the “call” button in the device 100.

Referring to FIGS. 2 and 7, in some examples, the display screen 43 candisplay the “call” button 53 as an icon selectable by the patient 9 viathe user interface provided by the display screen 43 and which places acall to a remote location associated with or assigned to the icondisplayed by the display screen 43 in response to actuation of the icon.In stage 800, the user can select a menu icon 850 displayed in a mainscreen of the user interface to cause the user interface to display amenu of options for controlling the external medical device 100. Themenu can include a settings icon 851 for opening a settings menu forsetting and controlling settings of the external medical device 100, asend data icon 852 for controlling the external medical device 100 totransmit data to a remote location, an activities icon 854 forcontrolling the external medical device 100 to perform one or moreoperations, such as, execute a diagnostics program or monitor aparticular type of data, and an icon for the “call” button 53. In stage802, the patient 9 can select the “call” button 53 to indicate a desireto call the remote location associated with the icon, which, in theexample shown in FIG. 8 is technical support.

In stage 804, the external medical device 100 can display a warningscreen to ensure that the user is calling the correct remote location.For example, as shown in FIG. 8, the warning screen can require thepatient 9 to again actuate an icon for the “call” button 53 whileproviding a warning that the patient 9 should call a doctor if thepatient 9 is experiencing a medical emergency. If the patient 9 actuatesthe icon for the “call” button 53, in stage 806 the external medicaldevice 100 initiates the call and displays a call screen indicating thatthe call has been initiated and providing an icon selectable by the userto “hide” the call screen and instead display the main screen (stage808) and an icon to end the call. Otherwise, the external medical device100 can return to the menu screen and await further instruction from theuser. After the call has been completed, the external medical device 100can display a call completed screen in stage 810 that indicates the callhas been completed and provides the user with an icon to return the userinterface to the main screen.

In an example and referring again to FIGS. 5 and 6, the external medicaldevice 100 can determine or select one or more of the remote locationsA, B, . . . N with which to initiate one or more communication links a1,a2, . . . aN . . . n1, n2, nN based on the data associated with theexternal medical device 100 and/or the patient 9 using the externalmedical device 100 at stage 706. For example, the external medicaldevice 100 may determine a telephone number to call or othercommunications address associated with a remote location and initiatethe call by executing the protocols required to establish thecommunication link. In another example, the external medical device 100can initiate the call, and the call can be routed to the selected remotelocation based on the data associated with the external medical device100 and/or the patient 9 using the external medical device 100.

The external medical device 100 can apply a plurality of rules to thedata associated with the external medical device 100 and/or the patient9 using the external medical device 100 to determine or select the oneor more remote locations A, B, . . . N with which to initiate acommunication link. The external medical device 100 can initiate asingle communication link, e.g., a1, with a remote location, e.g., A,and communicate different types and/or amounts of data over the singlecommunication link, or the external medical device 100 can initiatemultiple communication links, e.g., a1, a2, . . . aN, with a singleremote location, e.g., A, and communicate different types and/or amountsof data over the different communication links. The external medicaldevice 100 can determine a number of communication links to initiatewith a remote location based on a type and an amount of data thatrequired or requested to be sent to the remote location.

In some examples, a first remote location A can be a remote location forproviding technical support for the external medical device 100 and asecond remote location B can be associated with a caregiver of thepatient. In some examples, a third remote location C can be associatedwith emergency response services, e.g., a 911 services or rescue squad.

The external medical device 100 can select one of the first remotelocation A and the second remote location B based on data associatedwith an operation of the external medical device 100. For example, ifthe device 100 generates an error code, the first remote location A forproviding the technical support can be selected, and if the devicedetermines that the patient 9 is experiencing or has recently experiencea medical event, the second remote location B associated with thecaregiver of the patient can be selected.

In other examples, the external medical device can select each of thefirst remote location A and the second remote location B based on thedata associated with an operation of the external medical device 100 andinitiate a communication link with each of the first remote location Aand the second remote location B. The communication link with the firstremote location A can be separate and independent from the communicationlink with the second remote location B. Alternatively, a singlecommunication link that incorporates communications between the device100, the first remote location A, and the second remote location B canbe initiated by the device 100. For example, the device 100 can initiatea conference call between the patient 9, a doctor, and a relative of thepatient 9, or between the patient 9, technical support, and a caregiverof the patient 9.

In some examples, the patient or other user may be in need of trainingon or assistance with one or more aspects of the medical device 100. Assuch, the patient may initiate the communication link (e.g., by pressingthe “call” button or other such action) to request live support or oneor more training modules relating to the one or more aspects of thedevice 100. For instance, if the patient is need of training on how toassemble the garment associated with the device 100, he may initiate acommunication link to request the information. In some implementations,one or more patient service representatives may request, through the useof the “call” button, for assistance with garment fitting on thepatient.

Alternatively, the device 100 may automatically initiate thecommunication link in response to detecting an incorrect assembly forthe garment (e.g., detecting that one or more electrodes have beenincorrectly inserted into one or more pockets of the garment).Similarly, if the device 100 detects a device abuse indication, e.g.,the device 100 suffers an impact exceeding a threshold amount, thedevice may automatically initiate the communication link.

Once the link has been established, the device 100 can relay to theremote location supporting data relating to the event that triggered theautomatic call which may then be reviewed at the remote location (e.g.,technical support) and discussed with the user. Further, the device maybe configured to automatically download a relevant training module andthe user may either maintain the link for the duration of the trainingor end the communication and execute the training module. For example,the training module may be configured for independent patient and/oruser learning without a need for any other person's assistance.

In some implementations, a remote location may initiate a communicationlink to the device 100 for a number of reasons. For example, if apatient 9 has recently received treatment, the physician's office mayreceive notification of the treatment event. The physician or his or herdesignee may contact the patient 9 directly via the device 100 tocommunicate with the patient 9. Similarly, if a device event is noted(e.g., a device error code, or battery level is dangerously low), atechnician may initiate a communication link to the device 100, e.g., anaudio call to speak to the patient 9. In various implementations, theremote location and/or the patient 9 may communicate via textualmessages as provided in further detail below.

In another example, the external medical device 100 can determine orselect one or more of the remote locations A, B, . . . N with which toinitiate a communication link(s) based on data associated with aplurality of different possible remote locations. The data associatedwith the plurality of possible remote locations can include a type ofthe remote location (e.g., technical support, medical support, softwaresupport, etc.), a schedule of availability of the plurality of possibleremote locations (e.g., operating hours, personnel availability, etc.),a location of the plurality of possible remote locations, and a type ofpersonnel assigned to the plurality of possible remote locations (e.g.,doctor specialty, technical support specialty, etc.).

The external medical device 100 can receive the data associated with theplurality of possible remote locations directly from the remotelocations A, B, . . . N themselves, from the remote server 78, and/orfrom the remote data sources 600. The external medical device can applya plurality of rules to the data associated with the plurality ofpossible remote locations and the data associated with at least one ofthe external medical device and the patient using the external medicaldevice 100 to select one or more of the remote location A, B, . . . Nfrom the plurality of possible remote locations with which to initiate acommunication link(s). For example, a remote location may notify theexternal medical device 100 that it is no longer suitable for to contactat a particular time or with respect to a particular technical issue ormedical event, e.g., a remote location schedule is full or a particulartype of doctor or technical support agent is not available at the remotelocation, and the electronic medical device 100 can select a differentone or more of a the remote locations A, B, . . . N based on this data.

In an example, the external medical device 100 can determine or selectone or more of remote locations with which to initiate a communicationlink based on a previous communication link initiated by the device 100with a previous remote location. The remote location can be determinedor selected based on a plurality of different previous communicationlinks initiated by the device 100 with a plurality of different previousremote locations, e.g., data similar to a call history log. For example,the remote location can be selected based on a particular technicalsupport agent or doctor associated with the previous remote location.

For example, a history of a plurality of previous communication links asused herein can include details regarding a time when the link wasinitiated, an indication of the reason for the link (e.g., a technicalquestion, a device error, a health related question, a training request,or any other question), and/or any device or patient informationrecorded in association with the communication link. For example, a logmay be stored on the device 100 with all of or a portion of theavailable information associated with the plurality of communicationlinks. In some examples, a log may be stored at one or more remotelocations and made available to the device via a secure communicationlink as needed.

In another example, the external medical device 100 can determine orselect one or more of remote locations with which to initiate acommunication link based supporting data transmitted by the device 100to the previous remote location. For example, if technical informationabout the device 100 is to be sent to a remote location with which acommunication link is to be initiated by the external medical device100, the device 100 can determine based on the technical informationthat the communication link should be initiated with a particulartechnical support location based on the technical information about thedevice 100 if the same or similar type of information was previouslytransmitted to the particular location.

With continued reference to FIGS. 5 and 6, the external medical device100 initiates a communication link(s) with the selected remotelocation(s) at stage 708. In an example and as shown in FIG. 5, theexternal medical device 100 can initiate one or more of communicationlinks a1, a2, . . . aN with remote location A, one or more ofcommunication links b1, b2, . . . bN with remote location B, and/or oneor more of communication links n1, n2, . . . nN with remote location N.A communication link can comprise an audio and/or video communicationlink capable of communicating audio and/or video data between theexternal medical device 100 and a remote locations. The audio and/orvideo data may comprise live or real-time audio and/or video. Forexample, an audio and/or video communication link may comprise areal-time telephone call, a real-time video call (e.g., a Skype® call, aFaceTime® call, or other video conferencing call), a Push-to-Talk (PTT)connection, or other communication link capable of communicating audioand/or video data between two parties. In another example, one or moreof the communication links, e.g., a1, a2, . . . aN, between the externalmedical device 100 and a remote location, e.g., A, may comprise acommunication link that need not be an audio and/or video communicationlink. For example, one or more of the communication links may comprise adata communication between the external medical device 100 a remotelocation for the purpose of transmitting and/or receiving any type ofdata, e.g., the data associated with the external medical device 100and/or the patient 9 using the external medical device 100.

In an example, after initiating a first communication link with aselected first remote location, the external medical device 100 canautomatically, or in response to a user's request, initiate a secondcommunication link, e.g., b1, with the selected first remote location ora predetermined second remote location. In this manner, the device 100may be configured to maintain one or more concurrent or substantiallyconcurrent communication links with a plurality of remote locations.

The external medical device 100 can select a first remote location,e.g., remote location A, with which to initiate a communication linkbased on the data associated with the external medical device 100 and/orthe patient 9 using the external medical device 100. The remote locationA may be associated with a second remote location, e.g., remote locationB, in the external medical device 100 such that the external medicaldevice 100 automatically initiates a second communication link, e.g.,b1, with the second remote location B whenever the first communicationlink a1 is initiated with the first remote location A. For example, theexternal medical device 100 can automatically call the phone number of arelative or loved one simultaneously or substantially simultaneouslywith or in response to initiating a call with a medical professional ortechnical support. In this manner, the relative or loved one isimmediately notified when a medical event occurs, or the patient 9 isrequesting help with the device 100. In some examples, the relative orloved one can be conferenced directly into the call between the externalmedical device 100 and the medical professional or technical support.

With continued reference to FIGS. 5 and 6, the external medical device100 performs communications with the selected remote location(s) overthe established communication link(s) at stage 710. For example, audioand/or video data can be communicated over an audio and/or videocommunication link between the external medical device 100 and a remotelocation, and supporting data can be communicated over the same oranother communication link or channel between the external medicaldevice 100 and the remote location. For example, if the remote locationis a technical support agent, the patient 9 can communicate via audio,interactive two-way text messages, and/or video with the agent, e.g.,explain a problem or issue with the device and/or receive instructionsfor addressing the problem and/or issue. Supporting data, includingtechnical information about the device 100, can be communicated to theagent to assist the agent in providing technical support to the patient9 using the device 100. If the remote location is a doctor, the patient9 can communicate via audio, interactive two-way text messages, and/orvideo with the doctor, e.g., identify any symptoms or how they arefeeling or receive instructions on how to react to a medical event.Supporting data in this scenario, including patient or device data,e.g., an ECG signal of the patient, can be communicated to the doctor toassist the doctor in providing medical support to the patient 9 usingthe device 100.

In an example, the external medical device can be operable to record thedata associated with the external medical device 100 and/or the patient9 using the external medical device 100 for a predetermined time periodin response to a user instruction and automatically communicate therecorded data to a predetermined remote location. For example, in ahospital-based device as described herein, a nurse can instruct thedevice to record an ECG signal of the patient over a period of time andautomatically upload the ECG recording to a remote location foranalysis. In some examples, an identifier of the user providing theinstruction to record the data can be associated and transmitted withthe data to the remote location. For example, the nurse can be requiredto log on or satisfy an authentication procedure, e.g., a username andpassword, before providing instructions to the device 100, and theidentifier of the nurse can be associated with operations of the deviceand data recorded and/or received by the device a during a time periodin which the nurse is logged into the device as an authorized user. Thenurse can set particular settings in the device to correspond to thepatient 9 currently assigned to the device, e.g., different thresholdsfor automatic calls and/or alerts generated by the device 100 can be setfor different users.

In an example, the external medical device 100 can provide supportingdata to a remote location as noted above. The supporting data caninclude the data associated with the external medical device 100 and/orthe patient 9 using the external medical device 100. For example, asnoted above, the supporting data can include any of, without limitation,communication link-related data (e.g., an indication of a reason for thelink), patient's insurance information, compliance data, any deviceabuse information, patient training data, monitored physiologicalinformation (cardiac and non-cardiac data), and/or any other device orpatient information. The external medical device 100 can provide thesupporting data before initiating a communication link with the remotelocation, after initiating the communication link with the remotelocation, contemporaneously or substantially contemporaneously withinitiating and/or maintaining communication via the communication linkwith the remote location, and/or after terminating the communicationlink with the remote location. For example, the external medical device100 can send error codes or other technical information on the device100 to a remote location providing technical support before or duringinitiation of a call with technical support so that technical supportagent has data helpful in providing technical support for the device tothe patient via the call. In another example, the external medicaldevice may send patient data, e.g., ECG signals, to a remote location,such as, a doctor or a hospital, before, during, or after a call to thedoctor or hospital in response to a medical event occurring with thepatient 9 so that the doctor or hospital has data helpful in analyzingthe medical event and/or the patient 9.

The external medical device 100 can provide the supporting data to theremote location via a same communication link that is used for audio,video, and/or other communications with the remote location or aseparate link. In an example, the communication link can be routed tothe remote location based on the supporting data. For example, thesupporting data may include data including instructions for one or moreremote systems or devices to route the call to a particular remotelocation.

In another example, the patient 9 (or other user initiating a call) maybe prompted by the external medical device 100 to consent to thetransmission and release of the supporting data to the remote locationbefore the data can be transmitted to the remote location. The externalmedical device can provide a prompt to a user at least one of prior toinitiating the audio and/or video communication link and prior totransmitting data to the remote location over the audio and/or videocommunication link. The user prompt can comprise a prompt for userconsent to release information to the remote location. For example, theexternal medical device 100 can display a screen requesting that thepatient 9 confirm the transmission and release of the supporting data byactuating a button on the device 100 or an icon representing a button inthe user interface provided by the display.

The data communicated over the communication links, the supporting datatransmitted to the remote location from the external medical device 100,and any other data provided from or received by the external medicaldevice 100 can be protected by various encryption standards. Forexample, encryption standards that meet Health Insurance Portability andAccountability Act (HIPAA) compliance guides may be applied to datatransmitted from and received by the external medical device 10, suchas, using multi-factor authentication for encryption solutions and usingthe Advanced Encryption Standard (AES) for encryption algorithms, andcentrally managing all storage encryption.

In another example and with reference to FIG. 5, the external medicaldevice 100 can initiate a communication link with a remote location, andthe communication link can be routed to a sub-location of the remotelocation based on supporting data provided to the remote location. Asdiscussed herein, the external medical device 100 can provide thesupporting data before or contemporaneously with initiating acommunication link with the remote location via the communication linkitself or another communication link. The remote location, e.g., remotelocation A, can use the supporting data to determine if thecommunication link should be routed to one or more of sub-locations A1,A2, . . . AN. For example, if the external medical device 100 initiatesa communication link with a technical support location and transmitssupporting data indicating that the device has experienced a particulartype of software error, the technical support location can route thecommunication link to a sub-location suitable for addressing theparticular type of software error based on the supporting data, andforward the supporting data to the sub-location.

In an example and with continued reference to FIGS. 5 and 6, theexternal medical device 100 can receive a request for certain data fromone or more of the remote locations A, B, . . . N at stage 712. Theexternal medical device 100 can provide the requested data to therequesting remote location in response to the request at stage 714. Theexternal medical device 100 can transmit the requested data to theremote location over an existing communication link or initiate a newcommunication link for transmitting the requested data. For example, theexternal medical device 100 can have an already established audio and/orvideo communication link a1 with a remote location A, such as, atechnical support center, and, in response to the request for data,initiate another communication link a2 with the remote location A overwhich the requested data can be transmitted, such as, device diagnosticsdata, error codes, etc.

In another example, at stage 714, the external medical device 100 canprovide a remote location with direct access to certain data stored in amemory of the external medical device 100. For example, the externalmedical device 100 can provide direct access to device or patient datastored on the external medical device 100 such that the remote locationcan browse the data on the device 100 and download selected data fromthe device 100.

At stage 716, the external medical device 100 can terminate thecommunication link with the remote location and processing returns tostage 700. Although FIG. 8 shows that the external medical device 100receives the data at stage 700, the external medical device 100 canreceive the data throughout the entire process disclosed in FIG. 6. Insome examples, the external medical device can update communicationlinks, open new communication links with existing or new remotelocations, and/or communicate updated or modified data based on new dataassociated with the external medical device 100 and/or the patient 9using the external medical device 100 received during communication overa current communication link.

In one example, devices described herein can be capable of providingpatient training or assistance. After leaving a doctor's office or ahospital, a patient 9 that has been assigned a device 100 may be unsurehow to perform one or more operations associated with the device 100,e.g., changing batteries, applying electrodes, etc.

Referring to FIG. 9A, before the device 100 initiates a communicationlink, e.g., before placing a call or initiating an interactive two-waytext messaging session, the patient 9 can be prompted to indicate anature of and/or a preferred remote location for the communication. Inthis manner, in some implementations as described above, the patient'sinput can be used as a basis for classifying a category of the dataassociated with the communication link. For example, the device 100 canprovide the patient 9 with a series of options via the user interfacethat enables the patient 9 to indicate the nature of the communication,e.g., a technical question option, a device error code option, a healthrelated issue option, a training request option, a report a device issueoption, an “other” option, etc. In some implementations, the device 100may also present the patient 9 with a series of options that enable thepatient 9 to indicate a preferred remote location for the communicationlink. For instance, if the patient has reported a heath related issue,and selects to report a symptom, the patient may be afforded theopportunity to select to initiate a communication link with a caregiverto discuss the symptom, or a technician to provide more informationrelating to the symptom so that the information can be compiled into areport. The device 100 receives a selection from the patient 9 of anoption via the user interface, and determines the remote location basedon the option selected by the patient 9. The communication link can berouted to the remote location based on the option selected by thepatient 9.

In another example, and referring to FIG. 9B, the device 100 can providea text/image based interactive communication between the patient 9 and aremote location, (e.g., via text message, such as SMS message or MMSmessage, a real-time chat service, or other live support software thatprovides interactive communication between the patient 9 and a remotelocation), before, during, after, or in place of initiating an audioand/or video communication link with the remote location. For example,at stage 906, the device 100 can transmit a message including supportinginformation and/or the data received and/or sensed by the externalmedical device 100 to the remote location, e.g., to a technical supportlocation or a location of a doctor for the patient 9. At stage 908, themessages can be routed based on the data received and/or sensed by theexternal medical device 100, information included in the messages by thedevice 100 or the patient 9, a nature of the message or a remotelocation selected by the user in response to a prompt from the device100, or a remote location preset in the device 100. A communication linkcan be routed to a remote location based on the information in themessages exchanged in the interactive communication between the patient9 and the remote location. In one example, the device 100 can prompt theuser to indicate in a message to be transmitted the nature of thecommunication, e.g., a technical question option, a device error codeoption, a health related issue option, a training request option, areport a device issue option, and an “other” option, and the message oranother communication link can be initiated and routed to theappropriate remote location based on the indicated nature.

In an example, a remote location can initiate an interactivecommunication with the patient 9 via the device 100, for example, bytransmitting a message to the device 100. For example, a doctor for thepatient 9 may transmit a message asking the patient 9 if they took aprescribed medication on schedule, requesting the patient to perform anactivity while using the device 100 and send the monitoring results tothe location of the doctor, or to follow-up on a device or patientrelated issue.

In another example, the device 100 can automatically trigger a messageto be transmitted or a communication link to be initiated to the patient9 from a remote location based on the data associated with the externalmedical device 100 and/or the patient 9. For example, the device 100 cantrigger the message or communication link from the remote location inresponse to a determination of patient non-compliance with one or moreoperations or activities associated with the device 100 or the patientcondition, e.g., not switching the battery, incorrect application orpositioning of electrodes, or the patient 9 not wearing or using thedevice 100 in a prescribed manner, a device error code, a cardiac eventdetected for the patient 9, a detected pattern of the patient 9performing an operation incorrectly, such as, holding a response buttonwhen a response is not required, detected abuse of the device, such as,an impact threshold of an impact sensor in the device 100 beingtriggered, and/or various device performance issues, such as, slowdownloads, a pattern of device restarts or reboots, etc. The device 100can select the remote location from which to trigger the message basedon the data associated with the external medical device 100 and/or thepatient 9. For example, a battery issue can trigger a message from atechnical support location, while a cardiac event can trigger a messagefrom a location associated with a doctor or hospital. In one example,the device 100 can prompt the patient 9 to indicate whether he or sheneeds to speak with someone before triggering the message or thecommunication link from the remote location.

For example, the patient 9 may need training on one or more aspects ofthe device 100 if the patient 9 does not comply with device instructionsor the patient does not perform one or more requested or requiredactions. A remote location, such as, a technical support location, cansend a message to the device 100 for the patient 9 that includes optionsfor scheduling a call between the patient 9 and technical support. Thepatient 9 can respond with a message or selection that that indicates atime to schedule the call, an alternative phone number at which thepatient 9 wants to receive the call, and/or other information associatedwith the device or patient condition. If a more urgent issue exists,e.g., the patient 9 received a shock from the device 100 or the device100 predicts that the patient is at a high risk for cardiac event in afuture time period, the remote location can transmit a message to thepatient requesting that the patient 9 immediately contact the remotelocation, or the patient 9 can be automatically contacted by the remotelocation via the device 100.

The embodiments have been described with reference to various examples.Modifications and alterations will occur to others upon reading andunderstanding the foregoing examples. Accordingly, the foregoingexamples are not to be construed as limiting the disclosure.

What is claimed is:
 1. A wearable medical device comprising: anelectrode assembly comprising a plurality of ECG sensing electrodesconfigured to monitor a cardiac condition of a patient using thewearable medical device; a call button to initiate a call with a remotelocation; a transceiver configured to communicate information to andfrom the wearable medical device; and a memory; a controller comprisingat least one processor communicatively coupled to the electrode assemblyand the transceiver, the at least one processor configured to executeinstructions stored in the memory to receive, via actuation of the callbutton, a request to initiate a communication link with the remotelocation, provide, via a user interface, a confirmatory prompt that thepatient indicate confirmation to proceed with the request to initiatethe communication link with the remote location, initiate, via thetransceiver, the communication link to the remote location responsive toan indication of the confirmation to proceed with the request toinitiate the communication link.
 2. The wearable medical device of claim1, wherein the patient indicates a preference to proceed with therequest to initiate the communication link by actuating the call buttonagain after the confirmatory prompt is provided.
 3. The wearable medicaldevice of claim 1, wherein the confirmatory prompt comprises a warningscreen displayed on the user interface prompting the patient to call acaregiver if the patient is experiencing a medical emergency.
 4. Thewearable medical device of claim 1, wherein the call button comprises aselectable icon displayed on the user interface.
 5. The wearable medicaldevice of claim 1, wherein, after the patient initiates the call, the atleast one processor is configured to execute instructions stored in thememory to provide, via the user interface, a call screen indicating thatthe call has been initiated.
 6. The wearable medical device of claim 5,wherein the call screen comprises an icon selectable by the patient tohide the call screen and instead display a main screen.
 7. The wearablemedical device of claim 5, wherein the call screen comprises an iconselectable by the patient to end the call.
 8. The wearable medicaldevice of claim 1, wherein the user interface comprises a display screenconfigured as a touch screen.
 9. The wearable medical device of claim 1,wherein the remote location is selected by the patient from at least oneof an emergency response location, a technician location, a physicianlocation, a relative location, and a caregiver location.
 10. Thewearable medical device of claim 9, wherein the at least one processoris configured to execute instructions stored in the memory to provide,via the user interface, a plurality of selectable options that enablethe patient to indicate the remote location.
 11. The wearable medicaldevice of claim 10, wherein the at least one processor is configured toexecute instructions stored in the memory to provide the plurality ofselectable options as selectable icons displayed on a screen of the userinterface.
 12. The wearable medical device of claim 11, wherein theconfirmatory prompt comprises visual information on a display regardingthe remote location selected by the patient to allow the patient toreview the selected remote location before the communication link isinitiated.
 13. The wearable medical device of claim 11, wherein the atleast one processor is configured to execute instructions stored in thememory to provide, via the user interface, a text/image basedinteractive communication between the patient and the remote location.14. A wearable medical device comprising: an electrode assemblycomprising a plurality of ECG sensing electrodes configured to monitor acardiac condition of a patient using the wearable medical device; atransceiver configured to communicate information to and from thewearable medical device; a memory; and a controller comprising at leastone processor communicatively coupled to the electrode assembly and thetransceiver, the at least one processor configured to executeinstructions stored in the memory to detect a pattern of the patientperforming an incorrect device operation, and provide the patient withan option to initiate an audio and/or video communication link with aremote location based on detecting the pattern of the patient performingthe incorrect device operation.
 15. The wearable medical device of claim14, wherein the at least one processor is configured to executeinstructions stored in the memory to provide the option to initiate theaudio and/or video communication link via a user interface.
 16. Thewearable medical device of claim 15, wherein the at least one processoris configured to execute instructions stored in the memory to controlthe user interface to display the option on a display screen as an iconselectable by the patient via the user interface.
 17. The wearablemedical device of claim 15, wherein the incorrect device operationcomprises incorrect patient input to a user interface of the device. 18.The wearable medical device of claim 17, wherein the incorrect userinput comprises holding a response button when a response is notrequired.
 19. The wearable medical device of claim 14, wherein theincorrect device operation comprises a pattern of device restarts orreboots.
 20. The wearable medical device of claim 14, wherein theincorrect device operation comprises at least one of not switching thebattery, incorrect application or positioning of the plurality of ECGsensing electrodes, the patient not wearing or using the device in aprescribed manner, and a detected abuse event of the device comprisingan impact threshold of an impact sensor in the device being triggered.21. The wearable medical device of claim 14, wherein the at least oneprocessor is configured to execute instructions stored in the memory toprovide the patient with a prompt to indicate whether he or she needs tospeak with someone before initiating the audio and/or videocommunication link.
 22. The wearable medical device of claim 14, whereinthe wearable medical device comprises a wearable defibrillator.